Transcatheter prosthetic heart valve delivery system with recapturing feature and method

ABSTRACT

A delivery system for percutaneously deploying a prosthetic heart valve. The system includes an inner shaft assembly, a delivery sheath capsule and a handle maintaining a first actuator and a second actuator. The capsule is configured to compressively retain the prosthetic heart valve over the inner shaft assembly. The first actuator is operated to proximally retract the delivery sheath capsule and expose the prosthetic heart valve relative to the capsule. The second actuator is operated to proximally retract the prosthetic heart valve by transmitting forces to the inner shaft assembly.

BACKGROUND

The present disclosure relates to systems and methods for percutaneousimplantation of a heart valve prosthesis. More particularly, it relatesto systems and methods for transcatheter implantation of a stentedprosthetic heart valve, including partial deployment, recapturing, andrepositioning of the prosthesis at the implantation site.

Diseased or otherwise deficient heart valves can be repaired or replacedwith an implanted prosthetic heart valve. Conventionally, heart valvereplacement surgery is an open-heart procedure conducted under generalanesthesia, during which the heart is stopped and blood flow iscontrolled by a heart-lung bypass machine. Traditional open surgeryinflicts significant patient trauma and discomfort, and exposes thepatient to a number of potential risks, such as infection, stroke, renalfailure, and adverse effects associated with the use of the heart-lungbypass machine, for example.

Due to the drawbacks of open-heart surgical procedures, there has beenan increased interest in minimally invasive and percutaneous replacementof cardiac valves. With these percutaneous transcatheter (ortransluminal) techniques, a valve prosthesis is compacted for deliveryin a catheter and then advanced, for example, through an opening in thefemoral artery and through the descending aorta to the heart, where theprosthesis is then deployed in the annulus of the valve to be repaired(e.g., the aortic valve annulus). Although transcatheter techniques haveattained widespread acceptance with respect to the delivery ofconventional stents to restore vessel patency, only mixed results havebeen realized with percutaneous delivery of a relatively more complexprosthetic heart valve.

Various types and configurations of prosthetic heart valves areavailable for percutaneous valve procedures, and continue to be refined.The actual shape and configuration of any particular prosthetic heartvalve is dependent to some extent upon the native shape and size of thevalve being repaired (i.e., mitral valve, tricuspid valve, aortic valve,or pulmonary valve). In general, prosthetic heart valve designs attemptto replicate the functions of the valve being replaced and thus willinclude valve leaflet-like structures. With a bioprosthesesconstruction, the replacement valve may include a valved vein segmentthat is mounted in some manner within an expandable stent frame to makea valved stent (or “stented prosthetic heart valve”). For manypercutaneous delivery and implantation systems, the stent frame of thevalved stent is made of a self-expanding material and construction. Withthese systems, the valved stent is crimped down to a desired size andheld in that compressed arrangement within an outer sheath, for example.Retracting the sheath from the valved stent allows the stent toself-expand to a larger diameter, such as when the valved stent is in adesired position within a patient. In other percutaneous implantationsystems, the valved stent can be initially provided in an expanded oruncrimped condition, then crimped or compressed on a balloon portion ofcatheter until it is as close to the diameter of the catheter aspossible. Once delivered to the implantation site, the balloon ininflated to deploy the prosthesis. With either of these types ofpercutaneous stent delivery systems, conventional sewing of theprosthetic heart valve to the patient's native tissue is typically notnecessary.

It is imperative that the stented prosthetic heart valve be accuratelylocated relative to the native annulus immediately prior to fulldeployment from the catheter as successful implantation requires theprosthetic heart valve intimately lodge and seal against the nativeannulus. If the prosthesis is incorrectly positioned relative to thenative annulus, serious complications can result as the deployed devicecan leak and may even dislodge from the native valve implantation site.As a point of reference, this same concern does not arise in the contextof other vascular stents; with these procedures, if the target site is“missed,” another stent is simply deployed to “make-up” the difference.

While imaging technology can be employed as part of the implantationprocedure to assist a clinician in better evaluating a location of thetranscatheter prosthetic heart valve immediately prior to deployment, inmany instances, this evaluation alone is insufficient. Instead,clinicians desire the ability to partially deploy the prosthesis,evaluate a position relative to the native annulus, and reposition theprosthesis prior to full deployment if deemed necessary. Repositioning,in turn, requires the prosthesis first be re-compressed and re-locatedback within the outer delivery sheath. Stated otherwise, the partiallydeployed stented prosthetic heart valve must be “recaptured” by thedelivery system, and in particular within the outer sheath. While, intheory, the recapturing of a partially deployed stented prosthetic heartvalve is straight forward, in actual practice, the constraints presentedby the implantation site and the stented heart valve itself render thetechnique exceedingly difficult.

For example, the stented heart valve is purposefully designed to rigidlyresist collapsing forces once deployed to properly anchor itself in theanatomy of the heart. Thus, whatever tooling is employed to force apartially-deployed segment of the prosthesis back to a collapsedarrangement must be capable of exerting a significant radial force.Conversely, however, the tooling cannot be overly rigid to avoiddamaging the transcatheter heart valve as part of a recapturingprocedure. Along these same lines, the aortic arch must be traversed,necessitating that the delivery system provide sufficient articulationattributes. Unfortunately, existing delivery systems do not consider,let alone optimally address, these and other issues.

As mentioned above, an outer sheath or catheter is conventionallyemployed to deliver a self-deploying vascular stent. Applying this sametechnique for the delivery of a self-deploying stented prosthetic heartvalve, the high radial expansion force associated with the prosthesis isnot problematic for complete deployment as the outer sheath is simplyretracted in tension to allow the prosthetic heart valve to deploy. Werethe conventional delivery system operated to only partially withdraw theouter sheath relative to the prosthesis, only the so-exposed distalregion of the prosthetic would expand while the proximal region remainscoupled to the delivery system. In theory, the outer sheath could simplybe advanced distally to recapture the expanded region. Unfortunately,with conventional sheath configurations, attempting to compress theexpanded region of the stented prosthetic heart valve by distallysliding the sheath is unlikely to be successful. The conventionaldelivery sheath cannot readily overcome the radial force of the expandedregion of the prosthesis because, in effect, the sheath is placed intocompression and will collapse due at least in part to the abrupt edge ofthe sheath being unable to cleanly slide over the expanded region of theprosthesis. This effect is illustrated in a simplified form in FIGS.1A-1C. Prior to deployment (FIG. 1A), the stented prosthetic heart valveP is constrained within, and supports, the sheath S. With deployment(FIG. 1B), the sheath S is distally retracted, and the prosthesis Ppartially deploys. Where an attempt made to “recapture” the prosthesis Pby distally sliding the sheath (FIG. 1C), a leading end E of the sheathS abruptly abuts against the enlarged diameter of the prosthesis P, suchthat the distal end E cannot readily slide over the prosthesis P.Further, the sheath S is no longer internally supported and the radiallyexpanded bias of the prosthesis P causes the sheath S to buckle orcollapse.

In light of the above, a need exists for a stented transcatheterprosthetic heart valve delivery system and method that satisfies theconstraints associated with heart valve implantation and permits partialdeployment and recapturing of the prosthesis.

SUMMARY

Some aspects in accordance with principles of the present disclosurerelate to a delivery system for percutaneously deploying a prostheticheart valve. The prosthetic heart valve is radially self-expandable froma compressed arrangement to a natural arrangement. The delivery systemincludes an inner shaft assembly, a delivery sheath capsule, and ahandle maintaining a first actuator coupled to the delivery sheathcapsule and a second actuator coupled to the inner shaft assembly. Theinner shaft assembly includes an intermediate region providing acoupling structure configured to selectively engage a prosthetic heartvalve. The delivery sheath capsule is slidably disposed over the innershaft assembly and is configured to compressively retain the prostheticheart valve engaged with the coupling structure. With this construction,the delivery system is configured to provide a loaded state in which thecapsule compressively retains the prosthetic heart valve over the innershaft assembly. During use, the first actuator can be operated tofacilitate sliding of the capsule relative to the prosthetic heart valveso as to at least partially deploy the prosthetic heart valve relativeto the delivery sheath capsule. The second actuator is operated to applyproximal forces to the inner shaft assembly and the prosthetic heartvalve relative to the delivery system to facilitate recapture of theprosthetic heart valve.

Yet other aspects in accordance with principles of the presentdisclosure relate to a device for repairing a heart valve of a patient.The device includes a delivery system and a prosthetic heart valve. Thedelivery system includes the inner shaft assembly, the delivery sheathcapsule, and the handle, including the first actuator and the secondactuator, as described above. The prosthetic heart valve has a frame anda valve structure forming at least two valve leaflets attached to theframe. With this construction, the prosthetic heart valve isself-expandable from a compressed arrangement to a natural arrangement.With this construction, the device is configured to be transitionablebetween a loaded state, a partially deployed state, and a recapturingstate. In the loaded state, the prosthetic heart valve is coupled to theintermediate region of the inner shaft assembly, with the capsulecompressively retaining the prosthetic heart valve in the compressedarrangement. In the partially deployed state, the capsule is at leastpartially withdrawn from the prosthetic heart valve using the firstactuator such that a distal region of the prosthetic heart valve isexposed relative to the capsule and self-expands. In the recapturingstate, the second actuator is operated to position the delivery systemalong the distal exposed region of the prosthetic heart valve andsurround the prosthetic heart valve, due to proximal forces placed onthe inner shaft assembly using the second actuator.

Yet other aspects in accordance with principles of the presentdisclosure relate to a method of deploying a prosthetic heart valve toan implantation site. The method includes receiving a delivery systemloaded with a radially expandable prosthetic heart valve having a frameto which a valve structure is attached. The delivery system includes adelivery sheath capsule compressively containing the prosthetic heartvalve in a compressed arrangement over an inner shaft assembly in aloaded state. The prosthetic heart valve is delivered, in the compressedarrangement, through a bodily lumen of the patient and to theimplantation site via the delivery system in the loaded state. Thecapsule is proximally retracted relative to the prosthetic heart valvesuch that a distal region of the prosthetic heart valve is exposeddistal the capsule. The exposed, distal region self-expands toward adeployed arrangement. A position of the partially deployed prostheticheart valve relative to the implantation site is evaluated. Based uponthe evaluation, the prosthetic heart valve is proximally advancedrelative to the delivery system such that the delivery system isadvanced over the prosthetic heart valve.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1A-1C are simplified side views illustrating deficiencies ofexisting delivery sheaths or catheters to effectuate recapture of apartially deployed prosthetic heart valve;

FIG. 2 is an exploded, perspective view of a delivery system inaccordance with principles of the present disclosure and useful forpercutaneously delivering a prosthetic heart valve to a heart valveimplantation site;

FIGS. 3A-3E are simplified, cross-sectional views illustrating use ofthe delivery system of FIG. 2 in implanting a prosthetic heart valve,including partial deployment and repositioning thereof.

DETAILED DESCRIPTION

Current transcatheter heart valve delivery systems do not have thecapability of transcatheter valve repositioning in the antegrade orretrograde directions after deployment. The delivery systems of thepresent disclosure overcome these problems, and permit the clinician topartially deploy the prosthetic heart valve, and prior to release,reposition or recapture and remove it. In general terms, the systemfunctions by providing an actuator that serves to retract (i.e., byproviding a proximal force thereto) a partially deployed prosthesis toeffectuate recapturing of the partially deployed prosthetic heart valve.

As referred to herein, the prosthetic heart valve as used in accordancewith the various systems, devices, and methods of the present disclosuremay include a wide variety of different configurations, such as abioprosthetic heart valve having tissue leaflets or a synthetic heartvalve having a polymeric, metallic, or tissue-engineered leaflets, andcan be specifically configured for replacing any heart valve. Thus, theprosthetic heart valve useful with the systems, devices, and methods ofthe present disclosure can be generally used for replacement of a nativeaortic, mitral, pulmonic, or tricuspid valves, for use as a venousvalve, or to replace a failed bioprosthesis, such as in the area of anaortic valve or mitral valve, for example.

In general terms, the prosthetic heart valves of the present disclosureinclude a frame maintaining a valve structure (tissue or synthetic),with the frame having a normal, expanded arrangement and collapsible toa compressed arrangement for loading within the delivery system. Theframe is normally constructed to self-deploy or self-expand whenreleased from the delivery system. For example, the prosthetic heartvalve useful with the present disclosure can be a prosthetic valve soldunder the trade name CoreValve® available from Medtronic CoreValve, LLC.Other non-limiting examples of transcatheter heart valve prosthesesuseful with systems and methods of the present disclosure are describedin U.S. Publication Nos. 2006/0265056; 2007/0239266; and 2007/0239269,the teachings of each which are incorporated herein by reference.

The frames are support structures that comprise a number of struts orwire portions arranged relative to each other to provide a desiredcompressibility and strength to the prosthetic heart valve. In generalterms, the frames of the present disclosure are generally tubularsupport structures having an internal area in which valve structureleaflets will be secured. The leaflets can be formed from a verity ofmaterials, such as autologous tissue, xenograph material, or syntheticsas are known in the art. The leaflets may be provided as a homogenous,biological valve structure, such as porcine, bovine, or equine valves.Alternatively, the leaflets can be provided independent of one another(e.g., bovine or equine paracardial leaflets) and subsequently assembledto the support structure of the frame. In another alternative, the frameand leaflets can be fabricated at the same time, such as may beaccomplished using high-strength nano-manufactured NiTi films producedat Advance BioProsthetic Surfaces (ABPS), for example. The frame supportstructures are generally configured to accommodate at least two(typically three) leaftlets; however, replacement prosthetic heartvalves of the types described herein can incorporate more or less thanthree leaflets.

Some embodiments of the frames can be a series of wires or wire segmentsarranged such that they are capable of self-transitioning from acollapsed arrangement to a normal, radially expanded arrangement. Insome constructions, a number of individual wires comprising the framesupport structure can be formed of a metal or other material. Thesewires are arranged in such a way that the frame support structure allowsfor folding or compressing or crimping to the compressed arrangement inwhich the internal diameter is smaller than the internal diameter whenin the natural, expanded arrangement. In the collapsed arrangement, sucha frame support structure with attached valves can be mounted onto adelivery system. The frame support structures are configured so thatthey can be changed to their natural, expanded arrangement when desired,such as by the relative movement of one or more sheaths relative to alength of the frame.

The wires of these frame support structures in embodiments of thepresent disclosure can be formed from a shape memory material such as anickel titanium alloy (e.g., Nitinol™). With this material, the supportstructure is self-expandable from the compressed arrangement to thenatural, expanded arrangement, such as by the application of heat,energy, and the like, or by the removal of external forces (e.g.,compressive forces). This frame support structure can also be compressedand re-expanded multiple times without damaging the structure of theframe. In addition, the frame support structure of such an embodimentmay be laser-cut from a single piece of material or may be assembledfrom a number of different components. For these types of framestructures, one example of a delivery system that can be used includes acatheter with a retractable sheath that covers the frame until it is tobe deployed, at which point the sheath can be retracted to allow theframe to self-expand. Further details of such embodiments are discussedbelow.

With the above in mind, one embodiment of a transcatheter stentedprosthetic heart valve delivery system 30 is shown in FIG. 2. The system30 generally includes a stability layer 32, an inner shaft assembly 34,a delivery sheath assembly 36, and a handle 38. Details on the variouscomponents are provided below. In general terms, however, the deliverysystem 30 provides a loaded state in which a prosthetic heart valve (notshown) is coupled to the inner shaft assembly 34 and compressivelyretained within a capsule 40 of the delivery sheath assembly 36. Thedelivery sheath assembly 36 can be manipulated to withdraw the capsule40 proximally from the prosthetic heart valve via operation of thehandle 38, permitting the prosthesis to self-expand and release from theinner shaft assembly 34. Further, the handle 38 can be operated tomaneuver the inner shaft assembly 34 relative to the delivery sheathassembly 36 to position the capsule 40 over a partially deployed regionof the prosthetic heart valve to facilitate recapturing of theprosthesis within the capsule 40. In particular, proximal forces can beapplied to inner shaft assembly 34 in order to facilitate recapture ofthe prosthetic heart valve. As a point of reference, various features ofthe components 32-38 reflected in FIG. 2 and described below can bemodified or replaced with differing structures and/or mechanisms. Thus,the present disclosure is in no way limited to the stability layer 32,the inner shaft assembly 34, the delivery sheath assembly 36, the handle38, etc., as shown and described below. More generally, delivery systemsin accordance with the present disclosure provide features capable ofcompressively retaining a self-deploying, stented prosthetic heart valve(e.g., the capsule 40), a mechanism capable of effectuating release ordeployment of the prosthesis (e.g., retracting the capsule 40), and anactuator (e.g., associated with handle 38) that retracts the prosthesisto promote recapture.

The stability layer 32 illustratively includes a shaft 50, which forms alumen 52 (referenced generally) sized to be slidably received over theinner shaft assembly 34, terminating at a distal end 54. The shaft 50can take many forms and in general provides structural integrity tosystem 30, yet allowing sufficient flexibility to maneuver the capsule40 to a target site (e.g., the aortic valve). To this end, shaft 50, inone embodiment, is formed of a polymeric material with an associatedreinforcement layer. In other embodiments, the stability layer 32 can beeliminated. In yet other embodiments, stability layer 32 can facilitaterecapture by providing columnar strength support to recapture theprosthetic heart valve, for example, by sliding over capsule 40 orwithin capsule 40. In other embodiments, when stability layer 32 isconfigured to promote recapture, the stability layer 32 can be equippedto form a funnel shape at its distal end to recapture the prostheticheart valve.

Returning to FIG. 2, the remaining components 34-38 of the deliverysystem 30 can assume a variety of forms appropriate for percutaneouslydelivering and deploying a self-expanding prosthetic heart valve. Forexample, the inner shaft assembly 34 can have various constructionsappropriate for supporting a prosthetic heart valve within the capsule40. In some embodiments, the inner shaft assembly 34 can include aretention member 100, an intermediate tube 102, and a proximal tube 104.In general terms, the retention member 100 can be akin to a plunger, andincorporates features for retaining the stented prosthetic heart valvewithin the capsule 40 as described below. The tube 102 connects theretention member 100 to the proximal tube 104, with the proximal tube104, in turn, coupling the inner shaft assembly 34 with the handle 38.The components 100-104 can combine to define a continuous lumen 106(referenced generally) sized to slidably receive an auxiliary componentsuch as a guide wire (not shown).

The retention member 100 can include a tip 110, a support tube 112, anda hub 114. The tip 110 forms or defines a nose cone having a distallytapering outer surface adapted to promote atraumatic contact with bodilytissue. The tip 110 can be fixed or slidable relative to the supporttube 112. The support tube 112 extends proximally from the tip 110 andis configured to internally support a compressed prosthetic heart valvegenerally disposed thereover, and has a length and outer diametercorresponding with dimensional attributes of the selected prostheticheart valve. The hub 114 is attached to the support tube 112 oppositethe tip 110 (e.g., an adhesive bond), and provides a coupling structure120 (referenced generally) configured to selectively capture acorresponding feature of the prosthetic heart valve. The couplingstructure 120 can assume various forms, and is generally located alongan intermediate portion of the inner shaft assembly 34. In someconstructions, the coupling structure 120 includes one or more fingerssized to be received within corresponding apertures formed by theprosthetic heart valve frame (e.g., the prosthetic heart valve frame canform wire loops at a proximal end thereof that are received overrespective ones of the fingers when compressed within the capsule 40).

The intermediate tube 102 is formed of a flexible polymer material(e.g., PEEK), and is sized to be slidably received within the deliverysheath assembly 36. The proximal tube 104 can include, in someembodiments, a leading portion 122 and a trailing portion 124. Theleading portion 122 serves as a transition between the intermediate andproximal tubes 102, 104 and thus in some embodiments is a flexiblepolymer tubing (e.g., PEEK) having a diameter slightly less than that ofthe intermediate tube 102. The trailing portion 124 has a more rigidconstruction, configured for robust assembly with the handle 38 such asa metal hypotube, at a proximal end 126. Other constructions are alsoenvisioned. For example, in other embodiments, the intermediate andproximal tubes 102, 104 are integrally formed as a single, homogenoustube or solid shaft.

The delivery sheath assembly 36 includes the capsule 40 and a deliverysheath shaft 130, and defines proximal and distal ends 132, 134. Thecapsule 40 extends distally from the delivery shaft 130, and in someembodiments has a more stiffened construction (as compared to astiffness of the delivery shaft 130) that exhibits sufficient radial orcircumferential rigidity to overtly resist the expected expansive forcesof the prosthetic heart valve in the compressed arrangement. Forexample, the delivery shaft 130 can be a polymer tube embedded with ametal braiding, whereas the capsule 40 is a laser-cut metal tube.Alternatively, the capsule 40 and the delivery shaft 130 can have a moreuniform construction (e.g., a continuous polymer tube). Regardless, thecapsule 40 is constructed to compressively retain the prosthetic heartvalve at a predetermined diameter when loaded within the capsule 40, andthe delivery shaft 130 serves to connect the capsule 40 with the handle38. The delivery shaft 130 (as well as the capsule 40) is constructed tobe sufficiently flexible for passage through a patient's vasculature,yet exhibit sufficient longitudinal rigidity to effectuate desired axialmovement of the capsule 40. In other words, proximal retraction of thedelivery shaft 130 is directly transferred to the capsule 40 and causesa corresponding proximal retraction of the capsule 40. In otherembodiments, the delivery shaft 130 is further configured to transmit arotational force or movement onto the capsule 40.

The handle 38 generally includes a housing 140 and one or more actuatormechanisms (i.e., controls) 142 (referenced generally). The housing 140maintains the actuator mechanism(s) 142, with the handle 38 configuredto facilitate sliding movement of the delivery sheath assembly 36relative to the inner shaft assembly 34, as well as provide proximalforces to the inner shaft assembly 34 relative to the delivery sheathassembly 36 so as to retract the prosthetic heart valve into the capsule40. The housing 140 can have any shape or size appropriate forconvenient handling by a user. In one simplified construction, a first,deployment actuator mechanism 142 a includes a user interface oractuator (e.g., a deployment actuator) 144 slidably retained by thehousing 140 and coupled to a delivery sheath connector body 146. Theproximal end 132 of the delivery sheath assembly 36 is connected to thedelivery sheath connector body 146.

The inner shaft assembly 34, and in particular the proximal tube 104, isslidably received within a passage 148 (referenced generally) of thedelivery sheath connector body 146, and is rigidly coupled to thehousing 140 at proximal end 126. A second, recapture actuator mechanism142 b (referenced generally) similarly includes a user interface oractuator (e.g., a recapture actuator) 150 slidably maintained by thehousing 140 and coupled to the inner shaft assembly 34 via one or morebodies (not shown), facilitating movement of the inner shaft assembly 34with operation of the recapture actuator 150. With this but oneacceptable construction, the deployment actuator 144 can be operated toeffectuate axial movement of the delivery sheath assembly 36 relative tothe inner shaft assembly 34. Similarly, the recapture actuator 150 canbe manipulated to axially slide the inner shaft assembly 34 in aproximal direction relative to the delivery sheath assembly 36. Inparticular, the recapture actuator 150 can be axially slid relative tothe housing 140, transmitting proximal forces to the inner shaftassembly 34 and, in turn, the prosthetic heart valve coupled thereto. Assuch, the prosthetic heart valve can be recaptured by capsule 40 forrepositioning at a target site and/or retraction from a patient.

In one embodiment, recapture is facilitated by simultaneously providingdistal forces to delivery sheath capsule 40 (i.e., by pushing actuator144 relative to housing 140) as indicated by arrow 152 and proximalforces to inner shaft assembly 34 (i.e., by pulling actuator 150relative to housing 140) as indicated by arrow 154 (e.g., in a directionopposite to distal forces 152). In this embodiment, a ratio of distalforces 152 (i.e., applied to deployment actuator 144) to proximal forces154 (i.e., applied to recapture actuator 150) can be varied to provideforces necessary to facilitate recapture. For example, in one example,the distal forces 152 can be 25% of the recapture force while theproximal forces 154 are 75% of the recapture force. In another example,the ratio can be 50% distal forces 152 and 50% proximal forces 154. Inyet another example, the ratio can be distributed to be approximately25% distal forces 152 and approximately 75% proximal forces 154. Otherratios can further be employed.

FIG. 3A illustrates, in simplified form, loading of a prosthetic heartvalve 160 within the delivery system 30. In the loaded state of FIG. 3A,the prosthetic heart valve (also referred to as a prosthesis) 160 iscrimped over the inner shaft assembly 34, such that the prosthetic heartvalve 160 engages the coupling structure 120. The capsule 40compressively contains the prosthetic heart valve 160 in the compressedarrangement. Actuators 144 and 150 are coupled to housing 140(schematically shown), which includes a proximal end 162 and a distalend 164. As discussed above, deployment actuator 144 is coupled todelivery sheath assembly 36 and configured to move the delivery sheathassembly 36 relative to inner shaft assembly 34. In particular, in orderto move delivery sheath assembly 36 with respect to inner shaft assembly34, actuator 144 can be moved toward proximate end 162 of housing 140(i.e., causing proximal movement of capsule 40) and/or toward distal end164 of housing 140 (i.e., causing distal movement of capsule 40).Likewise, recapture actuator 150 is coupled to inner shaft assembly 34and thus prosthetic heart valve 160 to move the inner shaft assembly 34relative to the delivery sheath assembly 36. In particular, actuator 150can be moved away from proximal end 162 of housing 140 to apply proximalforces to prosthetic heart valve 160 and toward proximal end 162 toapply distal forces to inner shaft assembly 34 and prosthetic heartvalve 160.

To deploy the prosthetic heart valve 160 from the delivery system 30,the delivery sheath assembly 36 is withdrawn from over the prostheticheart valve 160, for example by proximally retracting the capsule 40 byoperating actuator 144 toward proximal end 162 of housing 140, such thatthe capsule distal end 134 is proximal the coupling structure 120. Oncethe capsule 40 is proximal the coupling structure 120, the prostheticheart valve 160 is allowed to self-expand to a natural arrangementthereby releasing from the delivery system 30.

In some instances, a clinician may desire to only partially deploy theprosthetic heart valve 160 and then evaluate before fully releasing theprosthetic heart valve 160. For example, the delivery system 30 loadedwith the prosthetic heart valve 160 can be employed as part of a methodto repair a damaged heart valve of a patient. Under these circumstances,the delivery system 30, in the loaded state, is advanced toward thenative heart valve implantation target site, for example in a retrogradeapproach, through a cut-down to the femoral artery and into thepatient's descending aorta. The delivery system 30 is then advancedusing tip 110, under fluoroscopic guidance, over the aortic arch,through the ascending aorta, and midway across the defective aorticvalve (for aortic valve replacement).

Once positioning of the delivery system 30 is estimated, the deliverysheath assembly 36, and in particular the capsule 40, is partiallyretracted relative to the prosthetic heart valve 160 as shown in FIG.3B. In particular, a force as indicated by arrow 166 is applied toactuator 144 to slide the actuator 144 toward proximal end 162 ofhousing 140. A distal region 170 of the prosthetic heart valve 160 isthus exteriorly exposed relative to the capsule 40 and self-expands. Inthe partially deployed arrangement of FIG. 3B, however, at least aproximal region 172 of the prosthesis 160 remains within the confines ofthe capsule 40, and thus coupled to the delivery system 30. As shown inFIG. 3C, further operation of actuator 144 due to a force indicated byarrow 174 that moves actuator 144 toward proximal end 162 of housing 140exposes a larger distal region 170 of prosthesis 160 whereas a smallproximal region 172 remains within capsule 40. In this partiallydeployed state, a position of the stented prosthetic heart valve 160relative to the desired implantation site can again be evaluated.

In the event the clinician believes, based upon the above evaluation,that the prosthesis 160 should be repositioned relative to theimplantation site, the prosthetic heart valve 160 must first becontracted and “resheathed” by transitioning the delivery system 30 to arecapturing state. As shown in FIG. 3D, the prosthetic heart valve 160and inner shaft assembly 34, along with tip 110 and coupling structure120, are proximally advanced relative to the capsule 40 by operatingactuator 150 away from proximal end 162, as indicated by arrow 180. Inparticular, proximal advancement of the prosthetic heart valve 160causes the capsule 40 to be maneuvered into contact with the exposeddistal region 170 of the prosthetic heart valve 160. The capsule 40readily slides along a surface of the prosthetic heart valve 160. In afurther embodiment, distal advancement of the capsule 40 can also beprovided by operation of actuator 144 away from proximal end 162 ofhousing 140, such force being indicated by arrow 182. By application offorce 180, potential trauma caused by exposed distal region 170 can bereduced, as further distal forces can cause distal region 170 to becomefurther embedded in tissue of a target site (e.g., the aortic arch). Asdiscussed above, the recapture of prosthetic heart valve 160 can furtherbe facilitated by advancing stability layer 32 in addition to, or inreplacement of, capsule 40 so as to promote recapture of prostheticheart valve 160. In this embodiment, layer 32 can provide columnarstrength to recapture valve 160. Stability layer 32 can be controlled byactuator 144 or a separate actuator, as desired.

Distal advancement of the capsule 40 and proximal advancement of theprosthetic heart valve 160 continues until capsule 40 enclosesprosthetic heart valve 160, as shown in FIG. 3E. In particular, actuator150 is further advanced away from proximal end 162 of housing 140 due toa force indicated by arrow 184. In one embodiment, the force 184 issimultaneously accompanied with a force indicated by arrow 186 onactuator 144 away from proximal end 162 of housing 140. While the distalregion 170 may or may not slightly compress in response to placementwithin the capsule 40, complete compression of the prosthetic heartvalve 160 does not occur. However, due to the combined forces 184 and186, compressive forces required to recapture the prosthetic heart valve160 are achieved. As shown in FIG. 3E, the capsule 40 is distallyadvanced to a recapturing state, forming an enclosed region that can berepositioned and/or retracted.

Once the prosthetic heart valve 160 is recaptured, the delivery system30 can be repositioned relative to the implantation site, and theprocess repeated until the clinician is comfortable with the achievedpositioning. Alternatively, the resheathed prosthetic heart valve 160can be removed from the patient.

The systems and methods of the present disclosure provide a markedimprovement over previous designs. By providing separate actuators forthe delivery sheath capsule and the inner shaft assembly, a partiallydeployed prosthesis is more readily recaptured.

Although the present disclosure has been described with reference topreferred embodiments, workers skilled in the art will recognize thatchanges can be made in form and detail without departing from the spiritand scope of the present disclosure.

What is claimed is:
 1. A delivery system for percutaneously deploying astented prosthetic heart valve, the system comprising: an inner shaftassembly including an intermediate portion providing a couplingstructure configured to selectively engage a prosthetic heart valve; adelivery sheath assembly slidably disposed over the inner shaftassembly, the delivery sheath assembly including a tubular capsule and adelivery shaft, wherein the capsule extends from a distal end of thedelivery shaft and is configured to compressively contain a prostheticheart valve engaged with the coupling structure; and a handle coupled tothe inner shaft assembly and the delivery sheath assembly, the handleincluding a housing having a proximal end and a distal end, the handlemaintaining a first actuator selectively applying forces to the deliverysheath assembly and a second actuator selectively applying forces to theinner shaft assembly to retract the prosthetic heart valve, the firstactuator and the second actuator being operated simultaneously relativeto the handle to apply forces to the delivery sheath assembly and theinner shaft assembly so as to promote recapture of the prosthetic heartvalve within the capsule, the first actuator is positioned between theproximal end and the distal end and includes a user interface slidablyretained by the housing, the user interface at least partially andslidably extending within a slotted opening to outside of the housing,wherein the first actuator is operated toward the distal end to applydistal forces to the delivery sheath capsule, the second actuator ispositioned at the proximal end, wherein the second actuator is operatedaway from the proximal end in a spaced apart relationship from theproximal end to apply proximal forces to the prosthetic heart valve. 2.The system of claim 1, wherein the system is configured to provide aloaded state in which the capsule compressively retains the stentedprosthetic heart valve over the inner shaft assembly.
 3. The system ofclaim 2, wherein the system is further configured to provide a partiallydeployed state in which the first actuator is operated to apply proximalforces to the delivery sheath capsule to expose a distal region of theprosthetic heart valve.
 4. The system of claim 3, wherein the system isfurther configured to provide a recapturing state in which after thesystem is in the partially deployed state, transition to the recapturingstate from the partially deployed state comprises the second actuatorbeing operated to apply proximal forces to the prosthetic heart valve sothat the delivery sheath capsule slides over and compresses theprosthetic heart valve such that the prosthetic heart valve iscompressed and retained within the delivery system.
 5. The system ofclaim 4, wherein the transition from the partially deployed state to therecapturing state further comprises the first actuator being operated toapply distal forces to the delivery sheath capsule.
 6. The system ofclaim 4, wherein in the recapturing state, the prosthetic heart valveplaced within the capsule has a greater diameter than in the loadedstate.
 7. A device for repairing a heart valve of a patient, the devicecomprising: a delivery system including: an inner shaft assemblyincluding an intermediate portion providing a coupling structure, adelivery sheath assembly slidably disposed over the inner shaftassembly, the delivery sheath assembly including a tubular capsule and adelivery shaft, wherein the capsule extends from a distal end of thedelivery shaft, a handle coupled to the inner shaft assembly, and thedelivery sheath assembly, the handle maintaining a first actuatorcoupled to the delivery sheath assembly and a second actuator coupled tothe inner shaft assembly; and a prosthetic heart valve having a frameand a valve structure attached to the frame and forming at least twovalve leaflets, the prosthetic heart valve being self-expandable from acompressed arrangement to a natural arrangement; wherein the device isconfigured to be transitionable between: a loaded state in which theprosthetic heart valve engages the coupling structure and iscompressively retained within the capsule, a partially deployed state inwhich the capsule is at least partially withdrawn from the prostheticheart valve upon operation of the first actuator such that a distalregion of the prosthetic heart valve is exposed relative to the capsuleand self-expands, and a recapturing state in which the prosthetic heartvalve is retracted into the delivery system upon simultaneous operationof the second actuator to a distance away from the handle to transmitproximal forces to the prosthetic heart valve and of the first actuatorbetween a proximal end and a distal end of the handle to apply distalforces to the delivery sheath capsule.
 8. The device of claim 7, whereinthe handle further includes a housing and the first actuator is operatedrelative to the housing to apply forces to the delivery sheath capsuleand the second actuator is moved to a distance away from the housing toapply forces to the inner shaft assembly.
 9. The device of claim 7,wherein the first actuator is operated toward the distal end to applydistal forces to the delivery sheath capsule and the second actuator isoperated away from the proximal end to apply proximal forces to theprosthetic heart valve.
 10. The device of claim 7, wherein in therecapturing state, the prosthetic heart valve placed within the capsulehas a greater diameter than in the loaded state.